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NCT04807504 · ClinicalTrials.gov registry record
Ropivacaine Pharmacokinetics in ESP Blocks
A clinical trial of Pain and Local Anesthetic Systemic Toxicity, sponsored by Thomas Jefferson University.
- Completed
- Registry status
- 20
- Enrollment target
- 1
- Study location
NCT04807504: Completed study of Pain and Local Anesthetic Systemic Toxicity, sponsored by Thomas Jefferson University.
NCT04807504 is a study of Pain and Local Anesthetic Systemic Toxicity that has completed, run by Thomas Jefferson University. The registered enrollment target is 20 participants, below the 304-participant average among 374 other Pain trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04807504, a study of Pain and Local Anesthetic Systemic Toxicity, has completed, sponsored by Thomas Jefferson University.
- COMPLETED
- Registry status
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a pharmacokinetic study to determine risk of local anesthetic systemic toxicity of ropivacaine when used in erector spinae plane blocks for thoracic surgery. Through serial blood sampling and the use of NONMEM population pharmacokinetic analysis this risk will be determined for the study population and other populations as well. Pain and quality of recovery will also be assessed.The erector spinae plane (ESP) block was first described in 2016 as a novel fascial plane block that provided analgesia for thoracic neuropathic pain. Since then hundreds of articles have been published that have reported use of the ESP block for indications such as rib fractures, breast surgery, abdominal surgery, and even shoulder surgery. It has also been studied in thoracic surgery and clinical experience confirms that patients undergoing video-assisted thoracoscopic surgery (VATS) or robot-assisted thoracic surgery experience satisfactory analgesia with ESP blocks. Because the block location is further from the neuraxis than both epidural and paravertebral blocks, ESP blocks have been suggested as a safer alternative to these older blocks but safety data have not yet been generated. In particular, the risk of local anesthetic systemic toxicity (LAST) has not been studied in ESP blocks. While the pharmacokinetics of ropivacaine used for thoracic paravertebral blocks have been established, similar studies have yet to be performed for the newer ESP block. Of particular concern for ESP blocks are two factors not present in some other blocks with established safety: 1). significant intercostal spread has been noted in anatomical studies, which could put patients at risk for LAST and 2). some of the proposed dosing regimens involve the intermittent injection of large bolus doses of local anesthetic. While measurement of arterial plasma levels is useful and necessary to study the safety of ropivacaine given in ESP blocks, the measurements alone do not allow for prediction of plasma lev
Conditions Studied
Interventions
- DRUG Ropivacaine
Study Locations (1)
Pennsylvania
- Thomas Jefferson University Hospital - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2021-03-26 |
| Est. Completion | 2021-09-23 |
What the finished NCT04807504 record still lists
NCT04807504 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 304-participant average among 374 other Pain trials with a reported enrollment target (93% lower).
The record links to 3 conditions, with Pain appearing as the primary indexed condition, and to 1 intervention - of which Ropivacaine is the first listed.
NCT04807504 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04807504 about?
NCT04807504 is a clinical study titled "Ropivacaine Pharmacokinetics in ESP Blocks". This is a pharmacokinetic study to determine risk of local anesthetic systemic toxicity of ropivacaine when used in erector spinae plane blocks for thoracic surgery. Through serial blood sampling and the use of NONMEM population pharmacokinetic analysis this risk will be determined for the study pop...
What is the current status of trial NCT04807504?
This trial is currently completed. The enrollment target is 20 participants. The study started on 2021-03-26. Estimated completion is 2021-09-23.
What conditions does trial NCT04807504 study?
This clinical trial studies the following conditions: Pain, Local Anesthetic Systemic Toxicity, Quality of Recovery.
What interventions are being tested in trial NCT04807504?
The interventions under investigation include: Ropivacaine (DRUG).
Who is sponsoring clinical trial NCT04807504?
This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04807504 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04807504's enrollment target sits among peer trials
20 338th of 374 higher than 29 of 374 other Pain trials
participants (enrollment target), bucketed by value
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